MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP L/XL 8HR; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0600

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Discoloration (2074); Blister (4537)

Event Date 03/13/2023

Event Type  Injury  

Event Description

On 17-mar-2023, a spontaneous report from the united states was received via telephone regarding a 65-year-old male consumer who used a thermacare lower back and hip 8hr l/xl heat wrap.On (b)(6) 2023, the consumer applied one thermacare lower back and hip heat wrap directly to his lower back and the side of his right thigh/hip.Approximately 6 hours after application, when the consumer removed the product the application site was itching.The next morning ((b)(6) 2023), he noticed blisters and a bumpy rash on his lower back and on the side of his right thigh.On (b)(6) 2023, he notified his primary doctor since the symptoms were still present.For treatment, the primary doctor prescribed 1% silver sulfadiazine cream.After using the silver sulfadiazine, the blisters turned black.He notified his doctor on (b)(6) 2023 and was advised to keep using the product.As of (b)(6) 2023, the consumers itching blisters and bumpy rash were ongoing.The consumer declined to provide further information.

Manufacturer Narrative

The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports "blisters and a bumpy rash".The cause of the consumer stating "blisters and a bumpy rash" are inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.

• Brand Name: THERMACARE LOWER BACK & HIP L/XL 8HR
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4234142221
• MDR Report Key: 16655620
• MDR Text Key: 312425365
• Report Number: 3007593958-2023-00018
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: GA0600
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 03/31/2023
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED ANTI-HYPERTENSIVE
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male